Kornimate/medical-research-clean huggingface dataset:
measurement of the pancreas function in patients with more than one pancreas after liver and small bowel transplantation

Conditions: Diabetes; Insulin Resistance; Liver/Small Bowel Transplant

Summary: under chronic immunosuppressive and corticosteroid therapy, transplant patients have a tendency to develop in the long-term diabetes. patients who have received extra pancreatic tissue with their liver and small bowel transplantation have not yet developed insulin resistance or diabetes mellitus. we would like to investigate to which level insulin secretory capacity the extra pancreas together with the native pancreas has in these transplant patients using the hyperglycemic clamp. these data will be compared with the data obtained from healthy controls.

the glycemic control in type 1 diabetic recipients of islet cell grafts is correlated with the ß-cell mass. in the standard technique for liver/small bowel transplant procedure previously described by grant et al, the pancreas was removed. this surgical method was modified by sudan et al and the donor pancreas was transplanted intact in these non-diabetic patients. under chronic immunosuppressive and corticosteroid therapy, these patients with extra ß-cell mass have not developed insulin resistance or diabetes mellitus. to which level insulin secretory capacity the extra pancreas allograft together with the native pancreas has in these transplant patients are not yet known. among the measures of pancreatic ß-cell-secretory capacity, the first-phase and steady state insulin secretion from the hyperglycemic clamp studies are believed to give the most robust estimates. moreover, the hyperglycemic clamp and the euglycemic clamp yield comparable estimates of insulin sensitivity and, so that under appropriate conditions, the hyperglycemic clamp technique may be used to assess both insulin sensitivity and insulin secretion in the same individual in a single experiment.

Eligibility criteria:
inclusion criteria: * liver/small bowel transplant patients with partial or whole pancreas * solitary small bowel transplant patients * insulin independent (no diabetes mellitus) * maintenance is with tacrolimus/azathioprine

Keywords: beta-cell function liver/small bowel transplant donor pancreas diabetes long-term immunesuppression
clinical trial to study the safety and effectiveness of mk0826 and other antibiotic therapy in patients with complicated urinary tract infection (0826-054)

Conditions: Urinary Tract Infections

Summary: the purpose of this study is to demonstrate that mk0826 is comparable to meropenem in the treatment of complicated urinary tract infections (utis) in adults.


Eligibility criteria:
inclusion criteria: * patient has a clinically suspected and /or bacteriologically documented complicated uti or acute pyelonephritis judged by the investigator to be serious * patient has one positive urine culture within 48 hours of enrollment * patient has one or more signs or symptoms of either upper or lower uti * patient is male with or without a bladder catheter or urologic abnormalities; or patient is a female with a history or clinical evidence of one or more urologic abnormalities exclusion criteria: * patient has received any amount of effective concomitant antibiotic therapy after obtaining the urine culture for admission to this study (admission urine culture) and prior to the administration of the first dose of study antibiotics * patient's infection has been treated with greater than 24 hours of systemic antibiotic therapy known to be effective against the presumed or documented pathogens within the 72 hour period immediately prior to consideration for entry into the study * patient has complete obstruction of any portion of the urinary tract. patient has a history of seizures other than an uncomplicated febrile seizure
sleep promotion in critically ill and injured patients cared for in the intensive care unit

Conditions: Sleep Deprivation

Summary: sleep deprivation in healthy volunteers is associated with immune dysfunction. this adverse effect of sleep deprivation likely occurs in patients suffering from acute injury and critical illness requiring intensive care unit (icu) admission. studies have demonstrated that sleep in icu patients is highly abnormal. the global hypothesis for this proposal is that a strategy to promote sleep in icu patients will increase time in rapid eye movement (rem) and slow wave sleep (sws). this three phase proposal examines the feasibility of a sleep promotion strategy for injured and critically ill patients in the icu. phase i (development and training): develop an intervention manual for sleep promotion, sleep enhancement program (sep), and train icu staff. phase ii (validation and safety): implement sep and test for protocol fidelity and safety. phase iii (efficacy): conduct a pilot trail to determine efficacy of sep to improve sws in icu patients.


Eligibility criteria:
inclusion criteria: * received care in icu for at least 3 days * received care in icu no longer than 14 days * score of 3 to 5 on the riker sedation-agitation scale (sas) * age \< 55 years * able to tolerate po or have gastric access present (nasogastric/orogastric/peg) exclusion criteria: * pregnancy * incarceration * admission diagnosis of closed head injury or traumatic brain injury * evidence of delirium on confusion assessment method (cam-icu) score * hemodynamic instability * sepsis * multiple organ dysfunction * acute renal failure * known history of sleep disorder * known psychiatric disorder

Keywords: sleep critical illness sleep promotion during recovery form illness
nivolumab with chemotherapy in refractory mds

Conditions: Myelodysplastic Syndromes

Summary: there is evidence of involvement of checkpoint pathways, including pd-1, in the pathogenesis and resistance of myelodysplastic syndrome (mds). however monotherapy with checkpoint inhibitors was ineffective in a number of studies, indicating the presence of several mechanisms of resistance. this pilot study evaluates the safety and preliminary efficacy of nivolumab combination with currently existing treatments in mds patients who failed at least one line of therapy. the study evaluates if there is a combination which induces objective responses.


Eligibility criteria:
inclusion criteria: * patients with myelodysplastic syndrome (mds) (up to 20% blasts) of any risk. patients with lower risk mds (low and int-1 by ipss) should have failed prior non-hypomethylating agent therapy (ie growth factors or lenalidomide). patients with higher risk mds (int-2 or high by ipss) should have failed prior at least one therapy with a hypomethylating agent or ara-c. * age 18 years or older. * no severe organ dysfunction: creatinine \<=2.5 x uln; serum bilirubin \<=2.5 x uln; ast and alt \<=5 x uln. * karnofsky index \>=70% * females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hcg) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception to avoid pregnancy for 24 weeks * males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 24 weeks after the last dose of nivolumab. exclusion criteria: * another malignancy requiring treatment at the time of inclusion * history of interstitial lung disease or pneumonitis * patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure nyha class iii or iv, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study * active, known or suspected autoimmune disease requiring treatment at the time of inclusion * pregnancy or breastfeeding * patients unwilling or unable to comply with the protocol * somatic or psychiatric disorder making the patient unable to sign informed consent * prior treatment with anti-pd-1, anti-pd-l1, or anti-ctla4 therapy

Keywords: myelodysplastic syndrome nivolumab 5-azacitidine cytarabine melphalan all-trans retinoic acid lymphodepletion
pd-1 antibody combined neoadjuvant chemotherapy for locally advanced cervical cancer

Conditions: Uterine Cervical Neoplasm; Uterine Cervical Cancer; Cervical Cancer

Summary: cervical cancer is one of the major health problems for chinese women. besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. however, not all patients respond well to neoadjuvant chemotherapy. this is an open-label, single-arm, multi-center clinical trial to evaluate whether pd-1 in combination with neoadjuvant chemotherapy will achieve better objective response rate.

subjects will receive therapy q3w until evaluation of efficacy. the first cycle include cisplatin and albumin-bound paclitaxel. a combination of anti-pd-1 antibody (shr-1210) with cisplatin and albumin-bound paclitaxel would be given in second and third cycles. patients who have demonstrated complete or partial tumour responses （cr/pr）will receive surgery and receive postoperative adjuvant therapy in accordance with nccn guideline. patients who have demonstrated stable disease or progressive disease （sd/pd）will receive concurrent radiochemotherapy.

Eligibility criteria:
inclusion criteria: 1. patients with locally advanced (2018 figo staged ib3, iia2 and iib/iiic1r（tumor size ≥ 4cm) ) cervical cancer and had not received any treatment before. 2. histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix. 3. pathological examination of the pd-l1 positive（combined score positive score≥1）. 4. females 18-70 years of age. 5. eastern cooperative oncology group score 0-1. 6. wbc≥3.5\*10\^9/l, neu≥1.5\*10\^9/l, platelet≥80×10\^9 /l; ast and alt ≤1.5 times normal upper limit; total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value. 7. well-compliance and willing to keep in touch. 8. willing to participate in this study, and sign the informed consent. exclusion criteria: 1. active or known or suspected autoimmune disease requires a system treatment as follows but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators. 2. hiv infection, active hbv/hcv. 3. condition requiring systemic treatment with small doses of corticosteroids within 1 months or large doses of corticosteroids within 3 months prior to randomization. 4. any primary malignancy within 5 years. 5. participate in other drug clinical trials at the same time. 6. pregnant or lactating female patients. 7. comorbidity including but not limited to: heart diseases (grade iii-iv cardiac insufficiency (nyha standard); central nervous system diseases or nonfunctional behavior; hematological system diseases; liver or kidney malformation or history of surgery. 8. drug or alcohol abuse. 9. unable or unwilling to sign informed consents. 10. not eligible for the study judged by researchers.
ephedrine for the treatment of congenital myasthenia

Conditions: Myasthenic Syndromes, Congenital

Summary: previous research has demonstrated possible efficacy of ephedrine in the treatment of congenital myasthenia caused by end-plate acetylcholinesterase deficiency. the aim of the current study is to test the hypothesis that ephedrine may be beneficial to these patients. to test this hypothesis we will perform a double blind, placebo-controlled, crossover study clinical efficacy and safety study. drug naïve patients who agree to participate will be randomized to two groups. each group will be treated in a blinded manner for 5 weeks with either placebo or ephedrine hcl in an escalating dose up to 100 mg per day divided in two doses. after five weeks the groups will cross over and continue treatment or placebo for a further five weeks. evaluations of strength and fatiguability will be done at baseline, at the end of each five week period and after a further two weeks. safety will be assessed weekly by the investigators using interview and physical examination. outcome measures will include barthel index, quality of life questionnaire, timed up and go, spirometry, timed elevation of limbs, and force measurements. all patients will report to the clinic as per study schedule (see appendix a). specifically, the 12 clinic visits will include: baseline (1), safety and efficacy assessments(10) and closeout (1).


Eligibility criteria:
inclusion criteria: * male or female patients , with congenital myasthenia, belonging to a previously reported kindred diagnosed with colq deficiency. exclusion criteria: * history of allergy to ephedrine or any inactive component. * significant abnormalities in screening cardiovascular parameters (blood pressure, pulse). * surgery within 6 weeks of screening. * concurrent use of any other medication except steroids. * pregnancy. * thyrotoxicosis. * co-morbid conditions or other neurological disorders that would confound assessment of clinical parameters. * participation in another clinical trial within 30 days of study start. * patients who are non-cooperative or parents/ legal guardians who are unwilling to sign consent form.

Keywords: congenital myasthenia ephedrine
study of a pd vwf/fviii concentrate, biostate®, in subjects with von willebrand disease

Conditions: Von Willebrand Disease

Summary: the aim of this study is to assess the pharmacokinetics (pk), efficacy, and safety of biostate® in subjects with von willebrand disease (vwd). pharmacokinetic component: pk parameters will be determined from a subgroup of subjects. subjects who complete the pk component will subsequently continue in the efficacy component of the study, either continuing on a previously established prophylaxis regimen or continuing to receive on-demand treatment with the occurrence of non-surgical bleeding (nsb) events. efficacy component: three treatment arms are defined for the efficacy component of the study. (1) subjects who are currently being treated on a set prophylaxis regimen with a vwf product at the time of study entry will be enrolled in the "prophylaxis" arm. (2) subjects not being treated on a set prophylaxis regimen at the time of study entry who require a vwf product for the treatment of nsb events will be enrolled in the "on-demand" arm and commence using biostate in the treatment of nsb events. (3) subjects enrolled in the "on-demand" arm have the possibility to enter the "cross-over to prophylaxis" arm to receive an additional 12 months of prophylactic treatment.


Eligibility criteria:
inclusion criteria: * diagnosed with vwd * desmopressin acetate (ddavp) treatment is ineffective or contraindicated or not available * evidence of vaccination against hepatitis a and b (or presence of antibodies against hepatitis a and b) within 10 years prior to their first dose of biostate® * written informed consent given exclusion criteria (for participation in the pk component): * actively bleeding immediately prior to initial pk period * have received ddavp or a vwf product in the 5 days prior to their first dose of study product * have type 2b, 2n or 2m vwd exclusion criteria (for all subjects): * requiring a vwf product for a planned surgical procedure at enrolment * have received aspirin or other non-steroidal anti-inflammatory drugs within 7 days prior to their first dose of study product * known history of, or are suspected to have, vwf or fviii inhibitors * suffering an acute or chronic medical condition, other than vwd, which may affect the conduct of the study * known or suspected hypersensitivity or previous evidence of severe side effects to biostate®, vwf/fviii concentrates, or human albumin * impaired liver function at screening * evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit * participation in a clinical study or use of an investigational compound in the 3 months preceding the first day of study drug administration, or plans to enter such a study during the study period. * females who are pregnant, breast-feeding or who have a positive pregnancy test at screening

Keywords: von willebrand disease
assessment of the phototoxic potential of leo 29102 cream

Conditions: Atopic Dermatitis

Summary: the purpose of this trial is to evaluate the phototoxic potential of a single application on healthy skin of leo 29102 cream in different doses.


Eligibility criteria:
inclusion criteria: * subjects having understood and signed an informed consent form * male adults between the age of 18 and 65 years (both inclusive) * healthy subjects without signs of skin irritation on test areas (erythema, dryness, roughness or scaling) * subjects willing and able to follow all the study procedures and complete the whole study * subjects affiliated to a social security system exclusion criteria: * females * males who are not willing to use a local contraception for the entire duration of the study, and refrain from fathering a child within 3 months following the study drug * systemic treatments which may interfere with the inflammatory reaction (e.g., corticosteroids and other anti-inflammatory drugs) within 2 weeks prior to randomisation * systemic or topical treatments suspected of causing photobiological reactions (e.g., tetracycline, thiazides, fluoroquinolones) within 4 weeks prior to randomisation * exposure to excessive or chronic uv radiation (i.e., sunbathing, solarium, phototherapy) within 4 weeks prior to inclusion or is planned during the study period * dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin types v and vi on the fitzpatrick scale) * scars, moles, sunburn or other blemishes in the test area which may interfere with grading * any systemic or cutaneous disease on the test area that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis) * relevant history of or concurrent photo-induced or photo-aggravated disease (abnormal response to sunlight * subjects with a history of serious allergy, allergic skin rash or known sensitivity to any component of the investigational products * subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last four (4) weeks before randomisation * participation in any other current interventional clinical trial based on interview of the subject * previously randomised in this trial * subjects impossible to contact in case of emergency * subjects known or, in the opinion of the investigator, are unlikely to comply with the clinical study protocol (e.g. alcoholism, drug dependency or psychotic state) * subjects who are in an exclusion period in the national biomedical research register of the french ministry of health * subjects under guardianship, hospitalised in a public or private institution for a reason other than research or subject deprived of freedom

Keywords: volunteers
compare effects of a soluble fiber on weight and blood cholesterol

Conditions: Obesity

Summary: obesity and type 2 diabetes have clearly been linked together and identified as epidemics in much of the developed world. historically several different dietary fibers have been used as means of reducing body weight and the related development of type 2 diabetes. these studies have generated mixed, if not inconsistent, results suggesting that none of these fibers promise a solution to either of these two conditions. we are proposing to investigate the effects of including a new soluble fiber, a-cyclodextrin, fbcx® (to be called y288 in this study), into the diet of adult overweight volunteers.

the overall aim is to investigate the effectiveness of a soluble dietary fiber, fbcx®, on weight loss and/or weight management, and blood lipid levels in overweight humans.

Eligibility criteria:
inclusion criteria: * 30 men and 30 women * age 18- 65 years * bmi 25.0 - 32.0 kg/m² * fasting glucose \<126 mg/dl * blood pressure \< 140/85 mm hg. hypertension on stable drug regimen using 2 or fewer antihypertensives will be acceptable. * total plasma cholesterol \<240 mg/dl, ldl-cholesterol \<160 and triglycerides \<400 mg/dl. hyperlipidemia on a stable medication regimen using single anti-hyperlipidemic drug acceptable. exclusion criteria: * pregnant women, women who plan to become pregnant during the study period * women who have given birth within the previous 12 months * lactating women * history or presence of type 2 diabetes; kidney disease; (creatinine \>1.4); liver disease (x2 fold increase in ast or alt); gout; cancer; untreated thyroid disease; gastrointestinal disease; other metabolic diseases or malabsorption syndromes * habitual low-fat intake (less than 20%) * history of eating disorder * subjects who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program * use of prescription or over-the counter anti-obesity medications or supplements (phenylpropanolamine, ephedrine, caffeine) for at least 6 months prior of study. * subjects with pacemakers will not participate in bioimpedance studies but will go through all the other testing.

Keywords: obesity diabetes soluble fiber overweight